FDA validator rule ID SD1148

Pinnacle 21 Support SDTM
1

Hi Jintao,

What version of validator and SDTM configuration do you refer?

Thank you,

Sergiy

2

Hi Sergiy,

The latest version we can find via COMMUNITY->VALIDATION RULES at this P21 website. The FDA Rules is also refer to the latest version. T

Thank you and best wishes,

Jintao

3

Below FDA validator rule is not implemented in the P21 tool. May I know the consideration behind?

FDA validator rule ID SD1148 - Start Date/Time of Treatment (EXSTDTC) variable value must be greater than or equal to Date/Time of Experimental Start Date (EXPSTDTC) in Trial Summary (TS) domain.